Checklist For (One or more of the ingredients of the

combination is a New Drug not approved

individually in the country however the same is

Checklist Item Description Item Type

s No
1 Covering letter File Upload

1 Module - Administrative/Legal Information Label

1.1 Covering letter File Upload

1.2 Comprehensive table of contents (Modules 1 to 5) File Upload

1.3 Administrative information Label

1.3.1 Treasury Challan (fee) Form Upload

1.3.1 Form12 & Challan Details File Upload

1.3.1 Application in Form 44 Form Upload

1.3.1 Legal and statutory documents (1.2.1, 1.2.2, 1.2.3, Label

1.2.4 for licence and approvals and 1.2.5, 1.2.6, 1.2.7,
1.2.8, 1.2.9, 1.2.10, 1.2.11 for legal documents
pertaining to application)
1.3.1 Copy of Form 11 for imported drug product File Upload

1.3.1 Form-29 for indigenous drug File Upload

1.3.2 Clinical Trial no objection letters / approval File Upload

1.3.2 A copy of plant registration / approval certificate File Upload

issued by the Ministry of Health / National Regulatory
Authority of the country of origin.
1.3.2 A copy of approval, if any, showing the drug is File Upload
permitted for manufacturing and/or marketing in the
country of origin.
1.3.2 Legal documents pertaining to application (to be Label
notarized):
1.3.2 A copy of Certificate of Pharmaceutical Product File Upload
(COPP) as per WHO GMP certification scheme for
imported drug
1.3.2 A copy of Free Sale Certificate (FSC) from the count ry File Upload
of origin for imported drug products.
1.3.2 A copy of Site Master File File Upload

1.3.2 Certificate of Analysis for three consecutive batches File Upload

1.3.2 Product Permission Document (PPD) as per Annex B File Upload

1.3.2 Copy of Form 11 for imported drug product File Upload

1.3.3 Name, address, telephone, fax, e-mail of other File Upload

manufacturer(s) involved in the production process
1.3.3 Non-proprietary name or common name of drug File Upload
product
1.3.3 Name, address, telephone, fax, e-mail of the File Upload
responsible official
1.3.3 Name, address, telephone, fax, e-mail of manufacturer File Upload
of drug substance
1.3.3 Name, address, telephone, fax, e-mail of the File Upload
manufacturing premises holding Market Authorization
of the drug product (for imported drug products)
Checklist Item Description Item Type
s No
1.3.3 Authorized Coordinates related to the application File Upload

1.3.3 Name, address, telephone, fax, e-mail of manufacturer File Upload

of drug product
1.3.3 Name, address, telephone, fax, e-mail of the File Upload
authorized agent in India: (for imported drug products)
1.4 Product Labeling (should conform to the specifications Label
under the Drugs and Cosmetics Rules 1945)
1.4.1 Package insert (in English) Monograph for health File Upload
professionals or information for prescription.
1.4.2 Secondary package label File Upload

1.4.3 Primary package label File Upload

1.4.4 Summary of product characteristics As per Annex C File Upload

1.4.5 Conditions of storage or conservation File Upload

1.4.6 Commercial presentation File Upload

1.4.7 Route of administration File Upload

1.4.8 Strength per dosage unit File Upload

1.4.9 Dosage Form File Upload

1.4.10 Composition (as per label claim) File Upload

1.4.11 Proprietary, commercial or trade name of drug product File Upload

1.4.12 General information on drug product Label

1.5 A copy of approval, if any, showing the drug is File Upload

permitted for manufacturing and/or marketing in the
country of origin.
1.6 Summary protocol of batch production and control. File Upload

1.7 A copy of Free Sale Certificate (FSC) from the country File Upload
of origin for imported drug products.
1.8 Domestic price of the drug followed in the countries of File Upload
origin in INR.
1.9 A brief profile of the manufacturer's research activity. File Upload

1.10 A brief profile of the manufacturer's business activity File Upload

in domestic as well as global market.
1.11 Information about the expert(s)/ Information regarding File Upload
involvement of experts, if any
1.12 Samples of pure drug substance and finished product File Upload
(an equivalent of 50 clinical doses, or more number of
clinical doses if prescribed by the Licensing Authority),
with testing protocols, full impurity profile and release
specifications.) (To be submitted to the laboratory as
directed by the Licensing Authority)
2 Rationale for combining them in the proposed ratio File Upload
and therapeutic justification along with supporting
literature.
2 Module - Summaries Label

2.1 Table of contents of Module 2 File Upload

2.2 Introduction File Upload

2.3 Quality overall summary Label

2.3.1 Summary of drug substance File Upload

Checklist Item Description Item Type
s No
2.3.2 Summary of drug product File Upload

2.4 Overview of non-clinical studies Label

2.4.1 Introduction and GLP statement File Upload

2.4.2 Summary of drug substance : General Information, File Upload

manufacture,characterization,control of drug
substance, reference standard or materials, container
closure system, stability
2.4.3 Overview of the non clinical testing strategy File Upload

2.4.4 Appendices File Upload

2.4.5 Pharmacology File Upload

2.4.6 Pharmacokinetics File Upload

2.4.7 Toxicology File Upload

2.4.8 Integrated overview and conclusions File Upload

2.4.9 List of literature File Upload

2.5 Non-clinical Summary Label

2.5.1 Overview of non-clinical studies Label

2.5.2 Introduction File Upload

2.5.3 Written summary of pharmacology File Upload

2.5.4 Overview of the non clinical testing strategy File Upload

2.5.5 Pharmacology File Upload

2.5.6 Tabular summary of pharmacology File Upload

2.5.7 Pharmacokinetics File Upload

2.5.8 Written summary of pharmacokinetics (if applicable) File Upload

2.5.9 Tabular summary of pharmacokinetics (if applicable) File Upload

2.5.10 Integrated overview and conclusions File Upload

2.5.11 Toxicology File Upload

2.5.12 Written summary of toxicology File Upload

2.5.13 Tabular summary of toxicology File Upload

2.5.14 List of literature File Upload

2.6 Overview of clinical studies Label

2.6.1 Introduction File Upload

2.6.2 Detailed discussion of product development File Upload

2.6.3 Written summary of pharmacology File Upload

2.6.4 Tabular summary of pharmacology File Upload

2.6.5 Overview of efficacy File Upload

2.6.6 Written summary of pharmacokinetics (if applicable) File Upload

2.6.7 Tabular summary of pharmacokinetics (if applicable) File Upload

Checklist Item Description Item Type
s No
2.6.8 Overview of safety File Upload

2.6.9 Conclusions on risk-benefit balance File Upload

2.6.10 Written summary of toxicology File Upload

2.6.11 Tabular summary of toxicology File Upload

2.6.12 List of literature File Upload

2.7 Clinical summary Label

2.7.1 Overview of clinical studies Label

2.7.2 Introduction File Upload

2.7.3 Table of contents File Upload

2.7.4 Summary of clinical studies of efficacy File Upload

2.7.5 Detailed discussion of product development File Upload

2.7.6 Summary of clinical studies of safety File Upload

2.7.7 Overview of efficacy File Upload

2.7.8 Overview of safety File Upload

2.7.9 Conclusions on risk-benefit balance File Upload

2.7.10 List of literature File Upload

3 Copy of valid manufacturing license in Form 25/28. File Upload

3 Module - Quality Information (Chemical, Label

Pharmaceutical manufacturing and control)
3.1 Table of contents for Module 3 File Upload

3.2 Pharmaceutical development Label

3.2.1 Justification of final qualitative/quantitative formula File Upload

3.2.1 Stabilization of active ingredient File Upload

3.2.1 Filling procedure for the active ingredient, in-process File Upload
controls
3.2.1 Selection and justification of critical steps File Upload

3.2.1 Manufacturing process development File Upload

3.2.1 Protocol of stability study, results and conclusions File Upload

3.2.1 Storage and shipping conditions of drug substance File Upload

3.2.1 Justification of specifications File Upload

3.2.1 Reference standards File Upload

3.2.1 Container closure system File Upload

3.2.1 Specifications of primary and secondary packing File Upload

3.2.1 Tests and evaluation of packaging materials File Upload

3.2.1 Stability of drug substance File Upload

3.2.1 Manufacturer(s) File Upload

Checklist Item Description Item Type
s No
3.2.1 Validation of manufacturing process [assay method, File Upload
impurity estimation method, residual solvent/other
volatile impurities(OVI) estimation method]
3.2.1 Manufacturing process for drug substance File Upload

3.2.1 Residual solvent/ other volatile impurities (OVI) File Upload

estimation
3.2.1 Impurities (name, manufacturer) File Upload

3.2.1 Complete monograph specification and STP File Upload

3.2.1 Analytical Data: Elemental analysis, Mass spectrum, File Upload

NMR spectra, IR spectra, UV spectra, Polymorphic
identification
3.2.1 Physical properties:- Description, Solubility, Rotation, File Upload
Partition coefficient, Dissociation constant.
3.2.1 Physiochemical data: (Chemical name and structure, File Upload
Empirical formula, Molecular weight)
3.2.1 Description and characterization of drug substance File Upload

3.2.1 Flow diagram of manufacturing process File Upload

3.2.1 Identification of critical steps in process and control File Upload

3.2.1 General description of raw materials File Upload

3.2.1 General information, starting materials and raw Label

materials
3.2.1 Drug substance(s): Information must be submitted for Label
each drug substance in the product.
3.2.1 Trade and/or non-proprietary name(s) of the drug File Upload
substance
3.2.1 Structural formula, molecular formula and relative File Upload
molecular weight (if applicable)
3.2.1 Drug substance(s) File Upload

3.2.2 Dissolution Study File Upload

3.2.2 Drug product File Upload

3.2.2 Manufacture of drug product File Upload

3.2.2 Description and composition of drug product File Upload

3.2.2 Description of manufacturing process File Upload

3.2.2 Protocol of stability study, results and conclusions File Upload

3.2.2 Stability of drug product File Upload

3.2.2 Tests and evaluation of packaging materials File Upload

3.2.2 Specifications of primary and secondary packing File Upload

3.2.2 Container closure system File Upload

3.2.2 Finished product specification and STP File Upload

3.2.2 Justification of specifications File Upload

3.2.2 Excipient compatibility study File Upload

3.2.2 In process quality control check and report File Upload

3.2.2 Certificate of analysis File Upload

Checklist Item Description Item Type
s No
3.2.2 Validation of analytical procedures File Upload

3.2.2 Comparative evaluation with international brand(s) or File Upload

approved Indian Brands in respect of Pack
presentation, dissolution, assay, impurities, content
uniformity & pH
3.2.2 Forced degradation study File Upload

3.2.2 Process validation protocol and Report File Upload

3.2.2 labeling File Upload

3.2.2 Details of equipment and facilities for production of File Upload

drug product: master formula, batch record and set
release documentation in respect of consistency
batches
3.2.2 Description of batch identification system File Upload

3.2.2 Control of excipients (adjuvant, preservative, File Upload

stabilizers and others)
3.2.2 Use of new adjuvants, preservatives, stabilizers and File Upload
excipients
3.2.2 Tests and evaluation of packaging materials File Upload

3.2.2 Protocol of stability study, results and conclusions File Upload

3.2.2 Approval/Permission for fixed dose combination: Label

3.2.2 Summary of Drug-Drug-Interactions (known and/or File Upload

expected) among the active ingredients present in the
FDC, along with its implications. This should be
prepared and signed by a competent person on behalf
of applicant.
3.2.2 Rationale for combining them in the proposed ratio File Upload
and therapeutic justification along with supporting
literature.
3.2.2 Data on pharmacokinetics/pharmacodynamics File Upload
combination
3.2.2 Any other data generated by the application on the File Upload
safety and efficacy of the combination
4 Module - 4 Label

4 Copy of valid Test license in Form 29 File Upload

4.1 Non Clinical Study Report File Upload

4.2 Animal Pharmacological Data Label

4.2.1 Follow-up and Supplemental Safety Pharmacology File Upload

Studies
4.2.1 General pharmacological actions File Upload

4.2.1 Specific pharmacological actions File Upload

4.2.1 Summary File Upload

4.2.2 Pharmacokinetics:- absorption, distribution, File Upload

metabolism, excretion
4.2.3 Male Fertility Study File Upload

4.2.3 repeated dose toxicity File Upload

4.2.3 Dermal toxicity File Upload

4.2.3 single dose toxicity File Upload

Checklist Item Description Item Type
s No
4.2.3 Systemic Toxicity Studies Label

4.2.3 Animal Toxicological data as per Appendix III to Label

Schedule Y
4.2.3 Female Reproduction and Developmental Toxicity File Upload
Studies
4.2.3 Local toxicity Label

4.2.3 Ocular toxicity File Upload

4.2.3 Inhalation toxicity File Upload

4.2.3 Vaginal toxicity File Upload

4.2.3 Photoallergy or dermal phototoxicity File Upload

4.2.3 Rectal tolerance test File Upload

4.2.3 Genotoxicity File Upload

4.2.3 Allergenicity/Hypersensitivity File Upload

4.2.3 Carcinogenicity File Upload

4.2.4 Single Dose toxicity File Upload

4.2.4 Photoallergy or dermal phototoxicity File Upload

4.2.4 Allergenicity/Hypersensitivity File Upload

4.2.4 Relevant local toxicity studies with proposed route of File Upload
clinical application (duration depending on proposed
length of clinical exposure)
4.2.4 In-vitro genotoxicity tests File Upload

4.2.4 Male Fertility Study File Upload

4.2.4 Repeat-dose systemic toxicity studies of appropriate File Upload

duration to support the duration of proposed human
exposure.
4.2.4 Dose Ranging Studies File Upload
4.2.4 Systemic Toxicity Studies Label

4.2.4 For Phase I Clinical Trial Label

4.2.5 Segment II reproductive/developmental toxicity study File Upload

(if female patients of child bearing age are going to be
involved)
4.2.5 In-vitro and In-vivo genotoxicity tests. File Upload

4.2.5 Repeat-dose systemic toxicity studies of appropriate File Upload

duration to support the duration of proposed human
exposure.
4.2.5 In case of an application for directly starting a Phase II File Upload
trial - complete details of the non-clinical safety data
needed for obtaining the permission for Phase I trial,
as per the list provided above must be submitted.
4.2.5 Provide a summary of all the non-clinical safety data File Upload
(listed above) already submitted while obtaining the
permissions for Phase I trial, with appropriate
references.
4.2.5 For Phase II Clinical Trials Label
Checklist Item Description Item Type
s No
4.2.6 In case of an application for directly initiating a Phase File Upload
III trial - complete details of the non-clinical safety
data needed for obtaining the permissions for Phase I
and II trials, as per the list provided above must be
provided.
4.2.6 In-vitro and In-vivo genotoxicity tests. File Upload

4.2.6 Reproductive/developmental toxicity studies File Upload

4.2.6 Segment I (if female patients of child bearing age are File Upload
going to be involved)
4.2.6 For Phase III Clinical Trials Label

4.2.6 Provide a summary of all the non-clinical safety data File Upload
(listed above) already submitted while obtaining the
permissions for Phase I and II trials, with appropriate
references.
4.2.6 Repeat-dose systemic toxicity studies of appropriate File Upload
duration to support the duration of proposed human
exposure.
4.2.6 Carcinogenicity studies (when there is a cause for File Upload
concern or when the drug is to be used for more than
6 months).
4.2.6 Segment III (for drugs to be given to pregnant or File Upload
nursing mothers or where there are indications of
possible adverse effects on foetal development)
5 Approval status of individual drugs in the country File Upload

5 Module - 5 Label

5.1 Table of contents of the Module File Upload

5.2 Clinical Study Report File Upload

5.2.1 General Pharmacological effects File Upload

5.2.1 Pharmacokinetics,Absorption,Distribution,Metabolism, File Upload

Excretion
5.2.1 Pharmacodynamics/early measurement of drug File Upload
activity
5.2.1 Specific Pharmacological effects File Upload

5.2.1 Summary File Upload

5.2.1 Human / Clinical pharmacology (Phase I) including Label

summary of the study and reports
5.2.2 Study Reports File Upload

5.2.2 Summary File Upload

5.2.2 Therapeutic exploratory trials (Phase II) Label

5.2.3 Study Reports File Upload

5.2.3 Summary File Upload

5.2.3 Clinical trial report (As per Appendix- II of Schedule Y) File Upload

5.2.3 Clinical trial protocol (As per Appendix- X of Schedule File Upload
Y)
5.2.3 Individual study reports with listing of sites and File Upload
Investigators.
5.2.3 Summary File Upload

5.2.3 Justification on Clinical trial waiver, if requested. File Upload

Checklist Item Description Item Type
s No
5.2.3 Therapeutic confirmatory trials (Phase III) Label

5.2.4 Study Reports File Upload

5.2.4 Phase IV studies and / or Pharmacovigilance Plan (if Label

applicable)
5.2.4 Summary File Upload

5.2.4 Clinical trial protocol (As per Appendix- X of Schedule File Upload
Y)
5.2.4 Clinical trial report (As per Appendix- II of Schedule Y) File Upload

5.2.4 Summary File Upload

5.2.5 Summary File Upload

5.2.5 Special Studies:- Label

5.2.6 Bio-availability / Bio-equivalence study protocol File Upload

5.2.6 Bio-availability / Bio-equivalence report File Upload

5.2.6 Synopsis File Upload

5.2.7 Ethics Committee approval (For new drug Institutional File Upload
ethics committee should require)
5.2.8 BE study centre approval by DCGI File Upload

5.2.9 Other studies e.g. geriatrics, pediatrics, pregnant, or File Upload

nursing women.
5.3 Authorization Letter from sponsor in favour of File Upload
Applicant
5.3.1 Study Protocol. (Phase of study) File Upload

5.3.2 Undertaking by the Investigators as per Appendix VII File Upload

of schedule Y
5.3.3 Patient Information Sheet(PIS)/ Informed consent form File Upload
(ICF) as per revised Appendix V of Schedule Y
5.3.4 List of Investigators in India including Site Addresses File Upload

5.3.5 Total number of patients enrolled globally and no of File Upload

Indian patients enrolled in the study
5.3.6 Total number of patients to be enrolled in India File Upload

5.3.7 Status of Drug in India and other Countries File Upload

5.3.8 Ethics Committee Approvals if Available File Upload

5.3.9 Investigators Brochure File Upload

5.3.10 IMPD Part 1 File Upload

5.3.10 IMPD Part 3 (Optional) File Upload

5.3.10 IMPD Part 2 (Optional) File Upload

5.3.10 Investigational Medicinal Products Dossier Label

5.3.10 IMPD Part 4 (Optional) File Upload

5.3.10 IMPD Part 5 (Optional) File Upload

5.3.10 IMPD Part 6 (Optional) File Upload

5.3.11 Sponsor undertaking regarding compensation as per File Upload

Rule 122DAB of D& C Rules, 1945
Checklist Item Description Item Type
s No
5.3.12 Financial disclosure agreement for study sites File Upload

6 Source of bulk drugs File Upload

7 Information on active ingredients which are Label

considered as IND
7.1 Physiochemical data (Chemical name and Structure, File Upload
Physical properties etc.)
7.2 Analytical data (elemental analysis, NMR spectrum, IR File Upload
Spectrum, UV spectrum etc.)
7.3 Complete monograph specification including File Upload
identification, identity / quantification of impurities,
enantiomeric purity, assay etc.)
7.4 Certificate of analysis File Upload

7.5 Validation [assay method, impurity estimation File Upload

method, residual solvent/other volatile impurities(OVI)
estimation method]
7.6 Reference standard characterization File Upload

7.7 Material safety data sheet File Upload

8 Data on Formulation: Label

8.1 Master Manufacturing Formula File Upload

8.2 Details of the formulation (including inactive File Upload

ingredients)
8.3 Finished Product Specification File Upload

8.4 In process quality control check File Upload

8.5 Process validation (Report) for three consecutive File Upload

batches
8.6 Validation of analytical method report File Upload

8.7 Certificate of analysis including identification, pH, File Upload

content uniformity, impurities, assay etc.
8.8 Comparative evaluation with pharmaceutical File Upload
equivalence with international brand(s) or approved
Indian brands, if applicable
8.9 Dissolution data in case of oral dosage forms as File Upload
appropriate
8.10 Stability study data report as per requirements of File Upload
schedule Y mentioning batch size. (should be
presented in tabular form with details of Batch No.,
Batch size, Date of Manufacturing, Date of initiation,
Packaging details)
9 Animal Pharmacology including summary of the study, File Upload
general pharmacological actions, specific
pharmacological actions, follow-up and supplemental
safety Pharmacology Studies, Pharmacokinetics
including absorption, distribution; metabolism;
excretion
10 Animal toxicology data as per Schedule Y. Label

10.1 Systemic toxicity studies Label

10.1.1 single dose toxicity File Upload

10.1.2 repeated dose toxicity File Upload

10.2 Male Fertility Study File Upload

Checklist Item Description Item Type
s No
10.3 Female Reproduction and Developmental Toxicity File Upload
Studies
10.4 Local toxicity Label

10.4.1 Dermal toxicity File Upload

10.4.2 Ocular toxicity File Upload

10.4.3 Inhalation toxicity File Upload

10.4.4 Vaginal toxicity File Upload

10.4.5 Photoallergy or dermal phototoxicity File Upload

10.4.6 Rectal tolerance test File Upload

10.5 Genotoxicity File Upload

10.6 Allergenicity/Hypersensitivity File Upload

10.7 Carcinogenicity File Upload

11 Human / Clinical pharmacology (Phase I) including File Upload

summary of the study and reports
12 Therapeutic exploratory trials (Phase II) File Upload

13 Therapeutic confirmatory trials (Phase III) File Upload

14 Regulatory status in other countries, as appropriate. Label

14.1 Names of the countries where the drug is File Upload

marketed/approved
14.2 Names of the countries where package insert File Upload

14.3 Names of the countries where the drug is approved as File Upload
IND, withdrawn
14.4 Names of the countries where the drug is withdrawn, if File Upload
any, with reasons
14.5 Free sale certificate (FSC) or Certificate of File Upload
Pharmaceutical Product (COPP), as appropriate.
15 Clinical study protocol as per Annexure B File Upload
16 BA/BE study protocol (when applicable), as per File Upload
Annexure B
17 Copy of proposed Package Insert which should include File Upload
generic name of all active ingredients; composition;
dosage form/s, indications; dose and method of
administration; use in special populations;
contraindications; warnings; precautions; drug
interactions; undesirable effects; overdose;
pharmacodynamics and pharmacokinetic properties;
incompatibilities; shelf-life; packaging information;
storage and handling instructions.
18 Draft specimen of the label and carton File Upload

19 Upload Justification for Quantity applied in Form-12, if File Upload

applicable
20 Upload duly signed Form-12 generated through this Form Upload
system , if applicable
21 Application in Form 44 Form Upload

22 TR-6 Challan Form Upload